NCT01541228

Photodynamic Treatment of Actinic Keratoses With Different Light Doses

Clinical Effect of Photodynamic Treatment When Treating Actinic Keratoses With Different Light Doses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.

Detailed description

To determine and compare clinical and histological effectiveness of different (70 J/cm2 ir 100 J/cm2) light doses when treating actinic keratoses with photodynamic therapy. To determine pain intensity during photodynamic therapy with visual analogue scale and factors influencing pain during the procedure.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DEVICE	Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source	Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK. Patients randomized so that half of them would receive a light dose of 70J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA. Treatment repeated twice with two weeks interval.
PROCEDURE	Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source	Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK. Patients randomized so that half of them would receive a light dose of 100J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA.Treatment repeated twice with two weeks interval.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-04-01
• Completion: 2013-04-01
• First posted: 2012-02-29
• Last updated: 2013-09-04

Locations

1 site across 1 country: Lithuania